Integra

INTEGRA is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment. The device consists of the following: • UCON • Integrated…

Registry build 21.09.26

INTEGRA is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment. The device consists of the following: • UCON • Integrated unit, includes the following:  Shock Wave Generator (SWAG)  Fluoroscopy device (X-Ray Module)  Patient Table The SWAG includes a high voltage generator module, a Reflector module, and a water module, and is located under the patient table. The Reflector is mechanically coupled to an X-Ray Tube Monoblock. The Reflector/ Monoblock assembly is attached via a U-arm to an Image Intensifier and a digital camera Module, for real time stone imaging. The U-Arm assembly is motorized, such that all three modules (Reflector, Monoblock, and Image Intensifier) move simultaneously as one piece and can be displaced electrically in all three axes, thus enabling the stone to be lined up in the therapeutic focal point. The patient and table do not move. The patient lies still on the table and only the U-Arm Assembly moves until the stone is localized. The UCON enables control over all operational aspects of the integrated unit via a software application. The operator chooses the various parameters to control the treatment including the number of shocks, intensity, frequency, etc. INTEGRA contains the necessary interfaces for ECG synchronization and ultrasonic imaging devices. INTEGRA can be used in any room equipped with the proper anesthesia equipment.

1manufacturer
1catalogue number
7510(k) clearances naming this product code

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code LNS
Manufacturer City Province Registered as Device types
Shenzhen Wikkon Precision Technologies Co., Ltd. Shenzhen Guangdong Manufacturer 1

Record

Regulatory record for Integra
Listed by Direx Systems Corp., United States
FDA product code LNS
Device type Lithotriptor, Extracorporeal Shock-Wave, Urological
Device class Class 2
Regulation 21 CFR 876.5990
Record published 2016-11-01
Record revised 2018-03-29 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Latex Contains natural rubber latex
Label carries lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Integra
Catalogue number Size Status
INTEGRA In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Piezolith 3000 Triple-Focus Lithotripsy System Complete United Medical Systems (DE), Inc. 47
Piezolith 3000 Triple-Focus Lithotripsy System Complete United Service Solutions, LLC 46
Modulith® Storz Medical AG 8
Dornier MedTech Dornier Medtech Gmbh 6
Econolith EM1000 Medispec, Ltd. 5
Econolith E3000 Medispec, Ltd. 2
Dornier Delta III Dornier Medtech Gmbh 2
Piezolith Richard Wolf Gmbh 2
Sonolith i-move Standard Module Edap TMS France SA 1
Compact Duet Direx Systems Corp. 1
ASADAL-M1 Huons Co., Ltd. 1
Econolith E2000 Medispec, Ltd. 1

Showing 12 of 20. All products under Lithotriptor, Extracorporeal Shock-Wave, Urological

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K111947 2012-03-01
K062147 2006-10-20
K053640 2006-03-01
K050091 2005-03-16
K041582 2004-07-07
K040470 2004-04-28
K023535 2003-01-17

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number Decision Trade name Approved to
P870018 1999-04-30 LITHOSTAR MULTILINE Siemens Healthcare Limited
P970019 1998-07-14 HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM Healthtronics Surgical Services, Inc.
P970062 1998-06-24 GENESTONE 190 LITHOTRIPTER Bmt, Inc.
P950043 1998-05-21 ECONOLITH(TM) LITHOTRIPTER Medispec, Ltd.
P870015 1998-03-05 MEDSTONE STS(TM) LITHOTRIPTER Medstone Intl., Inc.
P920034 1997-03-26 TRIPTER-X1 SERIES SHOCKWAVE LITHOTRIPTERS Medirex, Inc.
P920051 1996-06-21 STORZ MODULITH LITHOTRIPTER, MODEL SLX Karl Storz Endoscopy-America, Inc.
P840008 1995-10-05 DORNIER LITHOTRIPTER TRANSPORTABLE (DLT) Dornier Medtech America, Inc.
P890066 1994-04-18 THERASONIC LITHOTRIPSY TREATMENT SYSTEM Focus Surgery, Inc.
P880042 1994-04-18 EDAP LT.01 SHOCK WAVE LITHOTRIPTER Edap International Corp.
P880011 1992-02-10 TECHNOMED INTERNATIONAL SONOLITH 3000 (LITHORAY)TM Edap International Corp.
P890013 1991-09-09 RICHARD WOLF PIEZOLITH E.L.P. LITHOTRIPT MODEL2300 Richard Wolf Medical Instruments Corp.
P870011 1990-09-06 HMT SHOCK PLUG/LITHOTRIPTER ELECTRODE Towers Perrin

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

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5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer